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NCT02431247 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
A Phase 3 study, sponsored by Janssen Sciences Ireland UC.
- Completed
- Registry status
- Phase 3
- Development phase
- 725
- Enrollment target
NCT02431247 is a Phase 3 study that has completed, run by Janssen Sciences Ireland UC. The registered enrollment target is 725 participants.
The verdict
NCT02431247, a Phase 3 study, has completed, sponsored by Janssen Sciences Ireland UC.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 725 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.
Interventions
- DRUG DRV/COBI FDC
- DRUG Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
- DRUG FTC/TDF FDC
- DRUG D/C/F/TAF FDC - Matching Placebo
- DRUG FTC/TDF FDC Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 725 participants |
| Start Date | 2015-07-06 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02431247
The ClinicalTrials.gov registry entry for NCT02431247 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 725 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Sciences Ireland UC, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which DRV/COBI FDC is the first listed.
NCT02431247 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02431247 about?
NCT02431247 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects". The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) F...
What is the current status of trial NCT02431247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 725 participants. The study started on 2015-07-06. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT02431247?
The interventions under investigation include: DRV/COBI FDC (DRUG), Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC (DRUG), FTC/TDF FDC (DRUG), D/C/F/TAF FDC - Matching Placebo (DRUG), FTC/TDF FDC Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT02431247?
This trial is sponsored by Janssen Sciences Ireland UC, which has 7 total clinical trials registered on ClinicalTrials.gov.
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